BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 3285795 · Received August 14, 2013

    Report

    Report Number
    9673241-2013-00278
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 24, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM U.S.: CATALOG #: FG540000, SERIAL #: (B)(4). STOCKERT 70 SYSTEM U.S.: CATALOG #: S7001, SERIAL #: (B)(4). COOL FLOW PUMP U.S.: CATALOG #: CFP002, SERIAL #: (B)(4). PENTARAY NAV CATHETER U.S.: CATALOG #: D128202, LOT #: 15870491L. LASSO NAV VARIABLE ECO U.S.: CATALOG #: D134301, LOT #: 15833786L. ACUNAV 8F-90 CATHETER U.S.: CATALOG #: 10135910, OEM LOT #: G012506 (DISTRIBUTED). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE PHYSICIAN SUSPECTED A SLIGHT TAMPONADE BEFORE MAPPING. AFTER MAPPING AND BURNING, THE PATIENT'S BLOOD PRESSURE DROPPED. AN ECHO CONFIRMED A TAMPONADE AND PERICARDIOCENTESIS WAS PERFORMED. THREE HUNDRED FIFTY CC OF FLUID WAS REMOVED. THE PATIENT WAS STABILIZED AND DISCHARGED FROM THE HOSPITAL AT THE TIME OF THE CALL WHEN THEY REPORTED THE EVENT. THE REPORTER STATED THAT ALL THE CATHETERS USED WERE DISPOSED OF. ATTEMPTS TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT WERE PERFORMED WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389605 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S 15781678L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R